Clobetasol Propionate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Clobetasol Propionate
Generic name
CLOBETASOL PROPIONATE
Manufacturer
Xiromed, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
56e6d233-d9ee-f022-3be7-d100799a561e
SPL ID
c89c3b09-de28-9c1d-1f88-db05969f1868
Version
17
Effective date
2020-11-06
Source export date
2026-10-22
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-22/14398cbe7e22245154b804e51e14ec487486e2bb68b514fde0d7c34660e837f0/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 00:32:30
Harmonized routes table
Harmonized routes
TOPICAL

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: In controlled clinical trials, the most frequent adverse events reported for Clobetasol Propionate Ointment USP were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.